Who are we?

This position is responsible for overseeing the manufacturing and/or packaging of bulk oral solid dosage forms for shipment to end customer in accordance with EH&S standards ensuring a safe working environment and in compliance with all regulatory requirements and company policies and procedures. This is accomplished through managing resources and equipment and in collaboration with relevant support groups as needed. This position will assign priorities, evaluate work-in-progress, make decisions on the suitability of production materials and components, identify and implement productivity improvements (Operational Excellence), assist in investigations, assist in identification and implementation of new capital equipment for production, etc.

Responsible for:

• Responsible for ensuring that relevant training is current and documented and that operations are only performed by those with appropriate training and identifying and implementing improvement initiatives within assigned area (manufacturing or packaging).
• Coordination with relevant functional groups to ensure support for production activities in accordance with company priorities and published schedules.
• Evaluating work in progress and resolving production, quality, equipment and other issues by working with appropriate departments and making real time decisions in response to unexpected events.
• Supporting and assisting with investigations into production anomalies and laboratory results that do not meet expected standards.
• Determining the suitability for use of raw materials, intermediates and components relevant to production operations.
• The daily management and development of direct and indirect reports on multiple shifts, consulting production schedules and coordinating with supervisors, leads and supporting functional areas across multiple shifts to ensure assigned area (manufacturing or packaging) and equipment are prepared for scheduled operations.

Qualifications

Education/Certification/Experience:

• Requires Bachelor’s Degree, preferably in a scientific discipline, or equivalent education/experience with a minimum of 6 years relevant progressive experience in the pharmaceutical industry.
• Requires experience with and an in-depth knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems. (4 yrs in pharmaceutical production, preferably experience in the production of oral solid dosage forms. 3 yrs managing employees in a manufacturing environment.)

Skills/Knowledge/Abilities:

• Self-directed with ability to organize and prioritize work.
• Ability to motivate, influence and lead others with and/or without direct supervisory authority, positively manage conflict, provide difficult feedback and negotiate resolution, build and maintain collaborative relationships between teams, departments and business units, demonstrate sound judgment and decision making, identify the developmental needs of others and provide coaching, mentoring and encouragement to help others improve their knowledge or skills, and interact positively and collaborate with co-workers, management and external partners.
• Ability to analyze information and create metrics relevant to the business objectives.
• Project management and advanced presentation skills preferred.
• For Manufacturing area - knowledge of granulation, drug layering and particle coating (modified release formulations), for Packaging area – knowledge of blister and bottle packaging operational concepts.
• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), ERP system such as SAP or Oracle and manufacturing/quality systems such as Trackwise and Qdocs.

Function

Sub Function

Reports To

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